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NCT06041516 · ClinicalTrials.gov registry record · Phase 1

A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors

A Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT06041516 is a Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 178-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06041516, a Phase 1 study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Background: Neuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed. Objective: To test a new drug, ADCT-701, in people with NENs. Eligibility: Adults aged 18 and older with NENs. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor. ADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours. Participants may continue receiving treatment with the study drug for up to 2 years. After treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans. Follow-up visits will continue for up to 5 years after treatment began....

Interventions

  • DRUG ADCT-701

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2024-06-17
Est. Completion 2029-10-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT06041516

The ClinicalTrials.gov registry entry for NCT06041516 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (61% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 1 intervention - of which ADCT-701 is the first listed.

NCT06041516 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06041516 about?

NCT06041516 is a clinical study titled "A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors". Background: Neuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed. Objective: To test a new drug, AD...

What is the current status of trial NCT06041516?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2024-06-17. Estimated completion is 2029-10-30.

What conditions does trial NCT06041516 study?

This clinical trial studies the following conditions: Neuroendocrine Tumors, Carcinoma, Neuroendocrine, Neuroendocrine Carcinomas, Carcinoma, Adrenocortical, Carcinoma, Adrenal Cortical.

What interventions are being tested in trial NCT06041516?

The interventions under investigation include: ADCT-701 (DRUG).

Who is sponsoring clinical trial NCT06041516?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06041516 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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